314.90—Waivers.
(a)
An applicant may ask the Food and Drug Administration to waive under this section any requirement that applies to the applicant under §§ 314.50 through 314.81. An applicant may ask FDA to waive under § 314.126(c) any criteria of an adequate and well-controlled study described in § 314.126(b). A waiver request under this section is required to be submitted with supporting documentation in an application, or in an amendment or supplement to an application. The waiver request is required to contain one of the following:
(1)
An explanation why the applicant's compliance with the requirement is unnecessary or cannot be achieved;
(1)
The applicant's compliance with the requirement is unnecessary for the agency to evaluate the application or compliance cannot be achieved;